Total Hip ArthroplastyRTINCT02006251
Real-Time Instrument for Acetabular Shell Positioning
A study testing Real-time Instrumentation and Standard Total Hip Arthroplasty in people with Total Hip Arthroplasty, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Real-time Instrumentation and Standard Total Hip Arthroplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:
- Primary, unilateral anterior or posterior total hip arthroplasty
- 18 to 85 years old at time of surgery
- Able to get a pre- and post-operative CT scan at the Cleveland Clinic
Who cannot join
- Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
- Pregnancy
- Incarceration
- Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Acetabular Shell Position Using Real-Time Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial
The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty.
The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments.
The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Real-time Instrumentation, Standard Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, Acetabular positioning, Patient specific instrumentation, Preoperative planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time InstrumentationDevice
Also called RTI
To prepare the acetabulum and place the implants on the day of surgery, surgeons will receive either parts necessary to create the real-time with a surrogate model of the acetabular surface or standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will be provided with 3 parts necessary to create the real-time instrument: (1) a patient-specific surrogate bone model with a built-in guide pin trajectory which was planned in the 3D planning software, (2) a non-specific plastic arm available in different sizes, and (3) bone cement. The real-time instrument is created to position a peripheral guide wire on the acetabular rim to serve as a visual aid for reaming and impacting the acetabular shell using standard reaming tools supplied by the manufacturer. Once the acetabular shell is placed, the procedure is performed in the same manner for both groups, using the standard manufacturer instruments.
Standard Total Hip ArthroplastyProcedure or surgery
Total hip arthroplasty performed according to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard Total Hip Arthroplasty | Active comparator | Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty. Receives: Procedure: Standard Total Hip Arthroplasty |
| Real-time Instrumentation | Experimental | Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty Receives: Device: Real-time Instrumentation; Procedure: Standard Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Planned and Actual Values of Abduction
The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.
Measured: Through 2 weeks after surgery.
Secondary outcomes (2)
Difference Between Planned and Actual Values of Version
The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.
Measured: Through 2 weeks after surgery
Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups
Difference in the time for acetabular preparation and shell placement between the two groups were not collected
Measured: Intraoperatively (during surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Discretion of PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Barsoum, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006251
- Sponsor's protocol ID
- CCF 13-940
- Acronym
- RTI
- Status last verified
- Jan 2023
- First submitted
- 5 Dec 2013
- Last updated
- 10 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Small T, Krebs V, Molloy R, Bryan J, Klika AK, Barsoum WK. Comparison of acetabular shell position using patient specific instruments vs. standard surgical instruments: a randomized clinical trial. J Arthroplasty. 2014 May;29(5):1030-7. doi: 10.1016/j.arth.2013.10.006. Epub 2013 Oct 16.
PubMed 24231437
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Acetabular Shell Position Using Real-Time Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02006251
- Acronym / sponsor ID
- RTI / CCF 13-940
- Conditions
- Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, Acetabular positioning, Patient specific instrumentation, Preoperative planning
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discretion of PI
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Posted 1 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty.
The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments.
The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Total Hip Arthroplasty | Active comparator | Procedure: Standard Total Hip ArthroplastyEach surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty. |
| Real-time Instrumentation | Experimental | Device: Real-time Instrumentation, Procedure: Standard Total Hip ArthroplastyPre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:
- Primary, unilateral anterior or posterior total hip arthroplasty
- 18 to 85 years old at time of surgery
- Able to get a pre- and post-operative CT scan at the Cleveland Clinic
Key exclusion criteria (4 listed)
- Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
- Pregnancy
- Incarceration
- Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time InstrumentationAlso: RTITo prepare the acetabulum and place the implants on the day of surgery, surgeons will receive either parts necessary to create the real-time with a surrogate model of the acetabular surface or standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will be provided with 3 parts necessary to create the real-time instrument: (1) a patient-specific surrogate bone model with a built-in guide pin trajectory which was planned in the 3D planning software, (2) a non-specific plastic arm available in different sizes, and (3) bone cement. The real-time instrument is created to position a peripheral guide wire on the acetabular rim to serve as a visual aid for reaming and impacting the acetabular shell using standard reaming tools supplied by the manufacturer. Once the acetabular shell is placed, the procedure is performed in the same manner for both groups, using the standard manufacturer instruments. | Device | Real-time Instrumentation |
| Standard Total Hip ArthroplastyTotal hip arthroplasty performed according to standard of care | Procedure or surgery | Real-time Instrumentation, Standard Total Hip Arthroplasty |
Primary outcome
Difference Between Planned and Actual Values of Abduction
Time frame: Through 2 weeks after surgery.
The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.
2 secondary outcomes
Difference Between Planned and Actual Values of Version
Time frame: Through 2 weeks after surgery
Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups
Time frame: Intraoperatively (during surgery)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24231437Small T, Krebs V, Molloy R, Bryan J, Klika AK, Barsoum WK. Comparison of acetabular shell position using patient specific instruments vs. standard surgical instruments: a randomized clinical trial. J Arthroplasty. 2014 May;29(5):1030-7. doi: 10.1016/j.arth.2013.10.006. Epub 2013 Oct 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time Instrumentation and Standard Total Hip Arthroplasty in people with Total Hip Arthroplasty, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between Planned and Actual Values of Abduction (time frame: Through 2 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02006251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023; AzTrials last refreshed its copy on 27 Oct 2026.